21 CFR Part 878

119 regulation numbers covering 554 product codes in 21 CFR Part 878.

Regulations

119

Product Codes

554

21 CFR Part 878 Regulations

119 entries

Regulation Number	Product Codes	Device Name	Class
878.1800	EPY, JYK, KAG, FXE, FXF +1 more	Speculum, Ent	Class I
878.1820	OYD, ONV	Optical Diagnostic Device For Melanoma Detection	Class II
878.1830	QZS	Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer	Class II
878.1840	SHY	Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.	Class II
878.3250	FYI	Appliance, Facial Fracture, External	Class I
878.3300	OWZ, OXJ, OOD, OXL, OXN +38 more	Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction	Class II
878.3500	KDA, ODU, KKY, ESF	Prosthesis, Ptfe/Carbon-Fiber	Class II
878.3510	PQN	Carbon Dioxide Gas Controlled Tissue Expander	Class II
878.3530	FWM	Prosthesis, Breast, Inflatable, Internal, Saline	Class III
878.3540	FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	Class III
878.3550	LZK, FWP, MNF	Implant, Malar	Class II
878.3590	FZD	Prosthesis, Ear, Internal	Class II
878.3610	JCQ, MQR, ESW, MUM	Prosthesis, Esophagus	Class II
878.3680	FZE	Prosthesis, Nose, Internal	Class II
878.3720	NWA, NYT, JCT	Prosthesis, Tracheal, Preformed/Molded	Class II
878.3750	GBJ	Prosthesis, Adhesive, External	Class I
878.3800	NOJ, NOK, KCZ, GBI	Prosthesis, Breast, External, No Adhesive	Class I
878.3900	FZF	Splint, Extremity, Inflatable, External	Class I
878.3910	FYH, NOC, NOD, BTX	Splint, Extremity, Noninflatable, External, Sterile	Class I
878.3925	FTN	Plastic Surgery And Accessories Kit	Class I
878.4010	PJK, MPN, PLJ	Tissue Adhesive For Internal Use	Class II Class III
878.4011	OMD	Cutaneous Tissue Adhesive With Mesh	Class II
878.4013	SHA	Solid Wound Dressing With Permanently Bound Antimicrobial Agent	Class II
878.4014	OVR, NAB, PKD, PYL, PXY +6 more	Kit, First Aid, Talking	Class I
878.4015	NYS	Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)	Class II
878.4018	KOZ, MGO, NAC	Beads, Hydrophilic, For Wound Exudate Absorption	Class I
878.4020	MSA, NAD	Dressing, Wound And Burn, Occlusive, Heated	Class I
878.4022	NAE, PXQ, OJJ	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	Class I
878.4024	PBD	Composite Cultured Skin
878.4025	MDA, PFP	Elastomer, Silicone, For Scar Management	Class I
878.4040	QBW, OKI, FYF, FYC, BWP +20 more	Surgical Apparel With Material Claims	Class I Class II
878.4100	KGY	Bag, Intestine	Class I
878.4160	FTT, FWJ, FXT, KQM, FWD +17 more	Camera, Still, Surgical	Class I
878.4165	QCR	Wound Autofluorescence Imaging Device	Class I
878.4200	GBS, GBO, GCD, PXU, KGZ +18 more	Catheter, Ventricular, General & Plastic Surgery	Class I
878.4300	NJC, FZP, MVR, NVH, NEU +6 more	Clip, Vas Deferens	Class II
878.4320	FZQ, MKY	Clip, Removable (Skin)	Class I
878.4340	OOK, QPZ	Dermal Cooling Pack/Vacuum/Massager	Class II
878.4350	NEJ, FAZ, GEH	System, Cryosurgical, Liquid Nitrogen, For Gastroenterology	Class II
878.4355	QXW	Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer	Class II
878.4360	PMC	Scalp Cooling System	Class II
878.4370	PUI, KGW, FNW, PEM, KKX +10 more	Drape, Surgical, Exempt	Class II
878.4371	PQI	Wound Retraction And Protection System	Class II
878.4380	KGT	Drape, Adhesive, Aerosol	Class I
878.4400	SFQ, ODR, JOS, NUJ, OAB +19 more	Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision	Class II
878.4405	QGM	Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation	Class II
878.4410	NRB, NRJ	Wound Cleaner, Ultrasound	Class II
878.4420	PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	Class II
878.4425	QVX	Skin Patch For Treatment Of Hyperhidrosis	Class II
878.4430	QAI	Powered Microneedle Device	Class II
878.4440	HMP	Pad, Eye	Class I
878.4450	GDY	Gauze/Sponge, Internal, X-Ray Detectable	Class I
878.4452	PGZ	Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use	Class II
878.4454	POD	Temporary, Internal Use Hemostatic	Class II
878.4456	QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	Class II
878.4460	KGO	Surgeon'S Gloves	Class I
878.4470	KGQ	Cream, Gloving, Surgeon'S	Class I
878.4490	LMF, PMX, SGV, LMG	Agent, Absorbable Hemostatic, Collagen Based	Class III
878.4493	GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	Class II
878.4494	NWJ	Suture, Recombinant Technology	Class II
878.4495	GAQ, NJU, GAO, PTX	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	Class II
878.4550	QDG, QDF, QJF	Parathyroid Autofluorescence Imaging Device	Class II
878.4580	HBI, FST, FTA, FTG, QZN +12 more	Illuminator, Fiberoptic, Surgical Field	Class II
878.4590	OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	Class II
878.4630	FTC, KGL, MXG	Light, Ultraviolet, Dermatological	Class II
878.4635	REH, SGZ, RAB, LEJ, REG +1 more	Tabletop Sunlamp System	Class II
878.4650	KPK	Marker, Ostia, Aorto-Saphenous Vein	Class II
878.4660	FZZ	Marker, Skin	Class I
878.4670	PDW	Internal Tissue Marker	Class II
878.4675	QVS	Breast Implant Suction Retrieval Device	Class II
878.4680	GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	Class I
878.4683	QPX, OKO	Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical	Class II
878.4685	PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	Class II
878.4700	EPT, HRM, FSO, HRB	Microscope, Surgical	Class I
878.4730	KOY, KOX	Degreaser, Skin, Surgical	Class I
878.4740	GAG, QQS	Stapler, Surgical	Class I Class II
878.4750	NLL, OLL, GDW	Staple, Implantable, Reprocessed	Class II
878.4755	OMT	Absorbable Lung Biopsy Plug	Class II
878.4760	GDT, PYE	Staple, Removable (Skin)	Class I
878.4780	OMP, OTK, OJR, JCX, BTA +1 more	Negative Pressure Wound Therapy Powered Suction Pump	Class II
878.4783	QFC	Negative Pressure Wound Therapy Device For Reduction Of Wound Complications	Class II
878.4790	OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	Class II
878.4795	QYK	Semi-Automated Autologous Skin Graft Harvesting And Application Device	Class II
878.4800	MCZ, GED, LRY, PYF, NNC +110 more	Suture Removal Kit	Class I
878.4805	OXT	Percutaneous Surgical Set With Attachments	Class II
878.4810	ORK, QCY, LNK, OHS, OHT +14 more	Laser Assisted Lipolysis	Class I Class II
878.4815	PNL	Magnetic Surgical System	Class II
878.4816	SAH	Magnetic Compression Anastomosis System	Class II
878.4820	GFD, DWI, LXI, NWF, HWE +18 more	Dermatome	Class I
878.4825	PZQ	General Laparoscopic Power Morcellation Containment System	Class II
878.4830	GAL, OVN, GAN, GAK	Suture, Absorbable, Natural	Class II
878.4835	QML	Anal Fistula Closure Device	Class II
878.4840	NEW	Suture, Surgical, Absorbable, Polydioxanone	Class II
878.4850	QRL, QRM, QRK, FMK	Multiple Use Blood Lancet For Single Patient Use Only	Class II Class III
878.4860	OKJ	Light Based Treatment For Cold Sores Herpes Simplex Virus-1	Class II
878.4880	QPE	Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions	Class II
878.4930	KGS	Retention Device, Suture	Class I
878.4950	FSE, EPW, JEB, FZM, LWG +5 more	Table, Operating-Room, Manual	Class I
878.4960	GBB, JEA, GDC, LGX, FWW +1 more	Chair, Surgical, Ac-Powered	Class I
878.4961	QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	Class II
878.4962	SAB	Table Mounted Miniaturized Electromechanical Surgical System	Class II
878.4963	SAQ	Electromechanical System For Open Microsurgery	Class II
878.4964	SCV	Modular Electromechanical Surgical System	Class II
878.4965	SDD	Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field	Class II
878.5000	GAT, GAS	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II
878.5010	GAW, MXW	Suture, Nonabsorbable, Synthetic, Polypropylene	Class II
878.5020	GAR	Suture, Nonabsorbable, Synthetic, Polyamide	Class II
878.5030	GAP	Suture, Nonabsorbable, Silk	Class II
878.5035	NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	Class II
878.5040	QUB, MUU, QKL, QPB	Suction Lipoplasty System For Removal And Transfer	Class II
878.5050	PQM	Surgical Smoke Precipitator	Class II
878.5070	ORC, FRT, FZG, FYD, FZI +2 more	Air Filter Portable Apparatus	Class II
878.5080	QGI	Air-Handling Apparatus Accessory	Class I
878.5350	KCW	Epilator, High Frequency, Needle-Type	Class I
878.5360	KCX	Epilator, High Frequency, Tweezer-Type	Class I
878.5400	OLI, PKT	Fat Reducing Low Level Laser	Class II
878.5650	KPJ	Chamber, Oxygen, Topical, Extremity	Class II
878.5900	GAX, EYR, OJS	Tourniquet, Nonpneumatic	Class I
878.5910	KCY, QGX	Tourniquet, Pneumatic	Class I